Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial |
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Authors: | Alexander Teichmann Dan Apter Janusz Emerich Klaus Greven Dagmara Klasa-Mazurkiewicz Giambi B. Melis Marek Spaczynski Gary S. Grubb Ginger D. Constantine Daniele Spielmann |
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Affiliation: | aFrauenklinik, Klinikum Aschaffenburg, 63739 Aschaffenburg, Germany;bVäestöliitto/The Sexual Health Clinic, FIN-00100 Helsinki, Finland;cInstitute of Obstetric and Gynecology, Medical University of Gdańsk, 80-402 Gdańsk, Poland;d30459 Hannover, Germany;eDepartment of Obstetrics and Gynecology, University of Cagliari, 09124 Cagliari, Italy;fDepartment of Gynaecology, Obstetrics, and Gynaecologic Oncology, Division of Gynaecological Oncology, Poznan University of Medical Sciences, 61-535 Poznan, Poland;gResearch Headquarters, Wyeth Pharmaceuticals, Collegeville, PA 19426, USA;hWomen's Health, Wyeth Research, 92931 Paris, France |
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Abstract: | BackgroundThis Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen.Study DesignThree hundred twenty-three healthy women were randomized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year (13 pill packs). Pearl index, adverse event (AE) incidence and bleeding profiles were assessed.ResultsNo pregnancies occurred with the continuous oral contraceptive (OC) (Pearl index=0.00). As the study progressed, the percentage of women who achieved amenorrhea during each 28-day pill pack increased: 40% at pill pack 7, 53% at pill pack 13. The percentage of women with no bleeding [with or without spotting (defined as not requiring sanitary protection)] was 50%, 69% and 79% at pill packs 3, 7 and 13, respectively. The incidence of AEs was similar to that of the cyclic OC (except for metrorrhagia and vaginal bleeding in the first 6 months).ConclusionsContinuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC. |
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Keywords: | Continuous oral contraceptive Efficacy Levonorgestrel Menses suppression Safety |
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